Hemophilia ANCT06816056
Manual Therapy in Hemophilic Arthropathy of the Ankle
A study testing Manual Therapy in people with Hemophilia A, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction: Haemophilic ankle arthropathy manifests as functional (deficit in muscle strength, mobility and proprioception), intra-articular degenerative alterations and chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Manual Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteSpain
- Study dates
- 5 Feb 2025to 25 Jul 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with haemophilia A and B
- With severe haemophilia phenotype (<1% FVIII/FIX)
- Over 18 years of age
- With a medical diagnosis of ankle arthropathy and with clinical assessment using the Hemophilia Joint Health Score
- On prophylactic or on-demand treatment with coagulation factor VIII/FIX concentrates
Who cannot join
- Patients with neurological or cognitive disorders that prevent them from understanding the questionnaires and physical tests
- Failure to sign the informed consent document
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universidad Católica San Antonio
Murcia
Rubén Cuesta-Barriuso, PhD
About this study
Official title: Safety and Efficacy of Manual Therapy in the Treatment of Haemophilic Arthropathy of the Ankle. A Randomised Multicentre Clinical Trial
Introduction: Haemophilic ankle arthropathy manifests as functional (deficit in muscle strength, mobility and proprioception), intra-articular degenerative alterations and chronic pain. Manual therapy techniques are characterised by treating the soft tissues with the aim of modifying their density, relieving pain, reducing tissue sensitivity and improving the ranges of mobility. The objective is to evaluate the safety and effectiveness of a manual therapy protocol in patients with haemophilic ankle arthropathy.
Methods: Randomised crossover clinical trial. 13 patients with haemophilic ankle arthropathy from different regions of Spain will be recruited and randomised into two study groups (experimental and control). Each session of the experimental group will last 50 minutes, with 1 physiotherapy session per week for a period of 3 weeks. Patients will be evaluated at the beginning of the study, after the intervention and after a follow-up period of 4 weeks. The treatment programme includes 10 techniques that must be administered bilaterally. The study variables are the frequency of ankle haemarthrosis, range of movement, pressure pain threshold, pain intensity, joint status, biomechanical analysis of gait and balance, functionality and kinesiophobia.
Expected results: To evaluate the safety of manual therapy in patients with haemophilia. To observe changes in pain, mobility, joint condition, stability and functionality of the ankle, and kinesiophobia.
- Conditions
- Hemophilia A
- Being tested
- Manual Therapy, Placebo
- Keywords
- Hemophilic arthropathy, Ankle, Manual therapy, Joint pain
- Medical subject headings
- Hemophilia A, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyOther
The patients included in the experimental group will receive a 50-minute physiotherapy intervention involving global passive mobilisation, calcaneocuboid mobilisation, talus-navicular mobilisation, talar manipulation, tibial displacement manipulation, tibiotarsal decompression, plantar fascia induction, tibiotarsal unwinding and triceps surae induction techniques
PlaceboOther
The patients included in the control group will receive a 50-minute physiotherapy intervention in which the physiotherapist's hands and the times per technique will be the same as in the experimental group, but without applying any sliding, mobilisation or manipulation
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The intervention will last 3 weeks, with a periodicity of 1 weekly sessions. In total there will be 3 sessions lasting 50 minutes.
The techniques will be: global passive mobilisation, calcaneocuboid mobilisation, talus-navicular mobilisation, talar manipulation, tibial displacement manipulation, tibiotarsal decompression, plantar fascia induction, tibiotarsal unwinding traction technique and triceps surae induction technique Receives: Other: Manual Therapy |
| Control group | Placebo comparator | The patients included in the control group will receive the same physiotherapy intervention in the form of a placebo. The physiotherapist in charge of this intervention will perform the same number of techniques but without applying sliding stimuli, myofascial induction or manipulation. The hands will be positioned in the same way and the times per technique will be the same as in the techniques of the experimental group. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline hemarthrosis after treatment and at four weeks
A self-registration will be used to evaluate the frequency of bleeding, and thus the safety of the technique. This self-registration will be given to each patient at the beginning of the study and they must fill in the number of hemarthrosis and their main characteristics: date, origin (traumatic or spontaneous). The self-registration will be delivered to the evaluator in each of the study evaluations (post-treatment and follow-up).
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Secondary outcomes (6)
Change from baseline pressure pain threshold after treatment and at four weeks
Using a pressure algometer (model Wagner FPN100) we will measure the pain threshold to pressure, at the level of the joint and at a distance (in another part of the body). This device measures in Newton/cm2 the pressure at which the subject perceives pain under pressure. Pressure will be applied to the chosen point, which will be increased at a rate of approximately 50 kPa/s until the patient informs us that the sensation is starting to become painful. The lateral and medial malleoli of the ankle will be evaluated
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Change from baseline joint status after treatment and at four weeks
Change from knee and ankle joint status during treatment and follow-up period at four weeks. Measurement instrument: Haemophilia Joint Health Score (scale 0-20).
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Change from baseline range of motion after treatment and at four weeks
Change from range of movement of ankle during treatment and follow-up period at four weeks. The range of motion of the ankle joint will be measured using a universal goniometer, using the protocol for measuring joint motion described by the American Academy of Orthopaedic Surgeons
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Change from baseline joint pain after treatment and at four weeks
Change in ankle intensity during treatment and the four-week follow-up period. Ankle joint pain intensity will be measured using the visual analogue scale with a range of 0 to 10 points, where the higher the score, the greater the perception of joint pain
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Change from baseline functional capacity after treatment and at four weeks
Change in functional capacity during treatment and the four-week follow-up period. Functional capacity will be measured using the 2-Minutes Walking Test. The maximum distance that patients can cover in a period of six minutes walking as fast as possible will be measured. The unit of measurement is the metre, where the greater the distance, the better the functional capacity.
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Change from baseline kinesiophobia after treatment and at four weeks
Change in kinesiophobia during treatment and the four-week follow-up period. Fear of movement will be measured using the Tampa scale, which consists of 11 items on a 4-point Likert scale, with responses ranging from 1 (strongly disagree) to 4 (strongly agree). The lowest possible score, 11, denotes insignificant or non-existent kinesiophobia. The highest possible score, 44, denotes a severe fear of feeling pain when moving
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start5 Feb 2025 (estimated)
- Primary completion21 Jul 2025 (estimated)
- Study completion25 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Rubén Cuesta-Barriuso, Investigación en Hemofilia y Fisioterapia
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad de Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816056
- Sponsor's protocol ID
- HE-ANKLEran
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No